Associate Specialist, QA

Ansell; Kulim; On-site; MYR 72,000 - 108,000; Full time

Job summary

Ansell Limited in Kulim, Kedah, Malaysia, seeks an Associate Specialist, QA to maintain the plant's QMS and ensure GMP compliance. You will coordinate internal audits, support external certification audits, drive CAPA closure, and implement quality improvements across the site.

The role requires 2–3 years in Quality Assurance, knowledge of ISO 9001, and strong analytical and documentation skills, with occasional travel.

Qualifications

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or related discipline.
• Minimum 2–3 years of experience in Quality Assurance, Quality Systems, Document Control, Compliance, or related field.
• Knowledge of Quality Management Systems and ISO 9001 requirements.
• Knowledge of document control, CAPA, audit management, Management Review, and quality record requirements.

Responsibilities

• Maintain, monitor, and improve the plant QMS in line with ISO 9001 and GMP.
• Monitor quality indicators, objectives, and improvement initiatives; analyze trends.
• Coordinate document control and archival of quality records; remove obsolete documents.
• Plan and coordinate internal audits and support external audits.
• Maintain CAPA tracking and ensure timely closure and effectiveness verification.
• Support root cause investigations, risk assessments, and quality improvements.
• Coordinate and monitor QMS training and awareness activities.
• Prepare quality metrics and Management Review inputs; report progress.

Skills

Quality Management

ISO 9001

Document Control

CAPA

Audit Management

Root Cause Analysis

Statistical Analysis

MS Office (Excel, Word, PowerPoint)

Education

Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or related discipline

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Job Description - Associate Specialist, QA (30012289)

Job Description

Associate Specialist, QA - ( 30012289 )

Description

Why Ansell?

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. As the need for better protection continues to grow, Ansell remains committed to researching, developing, and investing in innovative products and technologies that are marketed under trusted global brands. Operating across two business segments—Industrial and Healthcare—Ansell employs approximately 14,000 people worldwide and continues to grow as a market leader.

Ansell is looking for an Assoc Specialist, QA to be based in Kulim, Kedah.

The Associate Specialist, QA is responsible for maintaining and ensuring the effectiveness of the Plant Quality Management System (QMS) and related procedures in compliance with applicable standards, regulatory requirements, customer expectations and Good Manufacturing Practices requirements. The role coordinates internal quality system audits and process audits to assess compliance and identify opportunities for continual improvement.

The incumbent provides training and awareness programs on quality-related requirements, supports the preparation of Management Review Meeting (MRM) inputs, tracks the closure of action items arising from management reviews, monitors Quality Objectives performance, and evaluates the effectiveness of implemented improvement initiatives.

The position is also responsible for coordinating and supporting external system certification audits, product audits, and customer audits, ensuring audit findings and corrective and preventive actions (CAPA) are effectively implemented, timely closed, and verified for effectiveness. Through effective monitoring, coordination, and reporting of QMS activities, the role contributes to sustaining compliance, driving continuous improvement, and enhancing overall quality performance across the plant.

What Can You Expect from Ansell?

• Work for a global leader in the health and safety protection solutions industry.
• A secure workplace with competitive remuneration and annual performance bonuses.
• An inclusive, collaborative, and supportive work environment.
• Exposure to a diverse and international workplace culture.

What Will Your Role Be?

• Maintain, monitor, and continuously improve the plant Quality Management System (QMS) in accordance with ISO 9001, internal procedures, regulatory requirements, customer expectations, and applicable Good Manufacturing Practices.
• Monitor QMS performance indicators, quality objectives, and improvement initiatives; analyze trends and prepare periodic quality reports.
• Coordinate the review, revision, approval, issuance, control, retention, and archival of quality documents and records, including removing obsolete documents from points of use.
• Plan and coordinate internal quality system and process audits, and support external certification, product, customer, and supplier-related audits.
• Maintain audit, nonconformance, and CAPA tracking systems; follow up with responsible departments to ensure timely closure and verification of effectiveness.
• Support root cause investigations, risk-based assessments, and the implementation of corrective, preventive, and quality improvement actions.
• Coordinate QMS-related training and awareness activities, maintain training matrices and records, and monitor training compliance and effectiveness.
• Compile quality metrics and inputs for Management Review Meetings, track resulting action items, and report progress through closure.
• Work with the supply team to maintain supplier qualification records and certifications, monitor certification expiry, and support supplier evaluation and requalification.
• Identify and support initiatives that strengthen QMS effectiveness, compliance, and overall plant quality performance.
• Escalate significant quality system risks or compliance concerns to management in a timely manner.
• Support urgent QMS activities, attend relevant quality and compliance training, and serve as an alternate champion for QMS-related projects when appointed.

What Will You Bring?

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or a related discipline.
• Minimum 2–3 years of experience in Quality Assurance, Quality Systems, Document Control, Compliance, or a related field, preferably in a manufacturing environment.
• Knowledge of Quality Management Systems and ISO 9001 requirements.
• Knowledge of document control, CAPA, audit management, Management Review, and quality record requirements.
• Basic knowledge of root cause analysis, risk-based thinking, artificial intelligence, and statistical analysis.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong analytical, reporting, planning, organizational, prioritization, and problem-solving skills.
• Effective written and verbal communication skills, with strong attention to detail.
• Ability to work collaboratively, demonstrate accountability, and take ownership of assigned responsibilities.
• Willingness to travel from time to time based on organizational and job requirements.

Work Locations

MY Kedah Kulim No 3 No 3 Jalan Perusahaan 2 Kulim Industrial Estate Kulim 09000